Pretomanid is an antibiotic medication used for the treatment of multi-drug-resistant tuberculosis affecting the lungs. It is generally used together with bedaquiline and linezolid. It is taken by mouth. Pretomanid belongs to the nitroimidazooxazine chemical class and is a prodrug that is bioactivated inside Mycobacterium tuberculosis by the deazaflavin-dependent nitroreductase Ddn with cofactor F420, producing reactive nitrogen species that impair mycolic acid synthesis and compromise respiratory metabolism under both aerobic and anaerobic conditions. The approved oral regimen in the BPaL protocol uses pretomanid 200 mg once daily with food for the designated treatment period. Key development and use considerations include dose administration with food to improve exposure, primary metabolism involving CYP enzymes with potential for drug interactions especially with strong CYP3A inducers, a terminal half-life in the range that supports once-daily dosing, and safety monitoring for hepatic effects, QT interval prolongation when combined with other QT-prolonging agents, and additive toxicities such as peripheral neuropathy when used with linezolid.
Parent: Pretomanid
Parent: Pretomanid
Parent: Pretomanid
![(6s, 6's)-6,6'-(4-(Trifluoromethoxy)-1,3-phenylene)bis(methylene)bis(oxy)bis(2-nitro-6,7-dihydro-5h-imidazo[2,1-b][1,3]oxazine)](https://veeprho.com/wp-content/uploads/2024/11/VE0022199-6s-6s-6-6-4-Trifluoromethoxy-1-3-phenylene-bis-methylene-bis-oxy.png "(6s, 6's)-6,6'-(4-(Trifluoromethoxy)-1,3-phenylene)bis(methylene)bis(oxy)bis(2-nitro-6,7-dihydro-5h-imidazo[2,1-b][1,3]oxazine)")
Parent: Pretomanid
![(6S)-6-[3-Methyl-4-(trifluoromethoxy)benzyl]oxy-2-nitro-6,7-dihydro-5H-imidazol[2,1-b][1,3]oxazine](https://veeprho.com/wp-content/uploads/2024/11/VE0022202-6S-6-3-Methyl-4-trifluoromethoxy-benzyl-oxy.png "(6S)-6-[3-Methyl-4-(trifluoromethoxy)benzyl]oxy-2-nitro-6,7-dihydro-5H-imidazol[2,1-b][1,3]oxazine")
Parent: Pretomanid
![(R)-8-Nitro-3-((4-(trifluoromethoxy)benzyl)oxy)-3,4-dihydro-2H-imidazo[5,1-b][1,3]oxazine](https://veeprho.com/wp-content/uploads/2024/11/VE0022203-R-8-Nitro-3-4-trifluoromethoxy-benzyl-oxy-3-4-dihydro-2H-imidazo-5-1-b-1-3-oxazine.png "(R)-8-Nitro-3-((4-(trifluoromethoxy)benzyl)oxy)-3,4-dihydro-2H-imidazo[5,1-b][1,3]oxazine")
Parent: Pretomanid
![(S)-2-Nitro-6-((3-(trifluoromethoxy)benzyl)oxy)-6,7-dihydro-5H-imidazo[2,1-b][1,3]oxazine](https://veeprho.com/wp-content/uploads/2024/10/VE0022146-S-2-Nitro-6-3-trifluoromethoxy-benzyl-oxy-6-7-dihydro-5H-imidazo-2-1-b-1-3-oxazine.png "(S)-2-Nitro-6-((3-(trifluoromethoxy)benzyl)oxy)-6,7-dihydro-5H-imidazo[2,1-b][1,3]oxazine")
Parent: Pretomanid
Parent: Pretomanid
Parent: Pretomanid
Parent: Pretomanid
Parent: Pretomanid
![6-Nitro-2-(((4-(trifluoromethoxy)benzyl)oxy)methyl)-2,3-dihydroimidazo[2,1-b]oxazole](https://veeprho.com/wp-content/uploads/2024/11/VE0022201-6-Nitro-2-4-trifluoromethoxy-benzyl-oxy-methyl-2-3-dihydroimidazo-2-1-b-oxazole.png "6-Nitro-2-(((4-(trifluoromethoxy)benzyl)oxy)methyl)-2,3-dihydroimidazo[2,1-b]oxazole")
Parent: Pretomanid
Typical quality specifications for pretomanid drug substance and tablets align with ICH-related-substance and impurity control principles: assay by validated HPLC 98.0 to 102.0 percent; total related substances not more than 1.0 percent by area; any single unspecified impurity not more than 0.2 percent by area; specified known related compounds and degradants set at tighter limits depending on toxicologic qualification for each impurity, for example a primary process-related impurity limited to 0.5 percent, a key oxidative or reduced degradant limited to 0.2 percent, and genotoxic or structurally related nitro-reduction products limited to 0.1 percent or below where warranted by qualification data. Residual solvents are controlled per ICH Q3C with Class 2 solvents below established ppm limits, elemental impurities are controlled per ICH Q3D, and total impurities in finished product are verified by stability studies to remain within specification across shelf life.
Pretomanid is an oral nitroimidazooxazine-class antibiotic used as part of a combination regimen to treat pulmonary multi-drug-resistant and extensively drug-resistant tuberculosis; it is a prodrug that requires activation by mycobacterial enzymes to exert bactericidal effects against M. tuberculosis.
Pretomanid received regulatory approval in recent years and is a relatively new treatment option for drug-resistant pulmonary tuberculosis, introduced after clinical trials established efficacy and safety as part of the BPaL regimen with bedaquiline and linezolid.
Availability varies by country and over time; access in India may be limited to national tuberculosis program channels, partner-supported programs, or special access schemes rather than broad retail distribution, so check current Indian regulatory listings and national TB program resources for up-to-date availability and access pathways.
Both delamanid and pretomanid are nitroimidazole-class prodrugs that require enzymatic reduction within M. tuberculosis; activation produces reactive species that inhibit mycolic acid synthesis and disrupt respiratory functions, with pretomanid activation dependent on the deazaflavin-dependent nitroreductase Ddn and cofactor F420, and both drugs can generate reactive nitrogen intermediates that contribute to bactericidal activity.
